CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 5,100 enrolled
Drug / intervention
Clopidogrel +1 moredrug
Likely dose
Clopidogrel 300mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00979589
NCT00979589Phase 3Completed
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Randomized,Double-blind Trial Comparing the Effects of a 3-month Clopidogrel Regimen,Combined With ASA During the First 21days,Versus ASA Alone for the Acute Treatment of TIA or Minor Stroke

Beijing Tiantan Hospital·interventional·Posted Sep 18, 2009·Updated Jul 15, 2020

In Brief

A Phase 3 clinical trial evaluating Clopidogrel and Placebo of clopidogrel and Asprin for Stroke and Transient Ischemic Attack. Completed, enrolled 5,100 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the effects of a 3-month regimen of clopidogrel initiated with a loading dose (LD) of 300 mg followed by 75 mg/day during the first 21days versus a 3-month regimen of ASA 75 mg/day alone on reducing the 3-month risk of any stroke (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom onset in high-risk patients with TIA or minor stroke.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke, Transient Ischemic Attack
CountriesChina
CollaboratorsUniversity of California, San Francisco

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 18, 2009
Enrollment StartDec 1, 2009
Primary CompletionMar 1, 2012
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.8 years ago

Interventions

Clopidogreldrug

The first group will receive a 300mg loading dose (LD) of clopidogrel on the day of randomization, followed by 75 mg clopidogrel/day from Day 2 to 3 months. ASA will be given in a total dose ranging between 75 mg and 300 mg (open label) on the first day, followed by blinded 75 mg once /day from Day 2 to Day 21st. Between Day 21st and 3-month visits, ASA 75 mg will be replaced by a placebo of ASA 75 mg.

Placebo of clopidogrel and Asprindrug

The second group will receive open label ASA in a total dose ranging between 75 mg and 300 mg on the first day, followed by blinded 75 mg once /day from Day 2 to 3 months. A placebo for clopidogrel will be given from the day of randomization until the 3-month visit.